Nucleic acid detection through modern molecular biological techniques has revolutionized diagnosis of infections, cancer, inborn genetic errors, HLA typing, and forensic and paternity testing. Methods to detect nucleic acids commonly requires several sample processing steps, including use of a lysis reagent to lyse cells and release the nucleic acids contained within the cells. Lysis reagents typically consist of a strong detergent such as sodium dodecyl sulfate and alkaline pH conditions.
The need for multiple processing steps when using a lysis reagent, such as one containing a strong detergent, primarily results from inhibitors of later nucleic acid detection steps that are present or associated with the lysis reagent. The inhibitors must be neutralized or removed before amplification or other additional steps in nucleic acid detection can proceed. These additional steps result in increased labor and materials costs for the clinical laboratory. Use of a lysis reagent for nucleic acid detection also is detrimental because it can, under some circumstances, degrade the nucleic acids, thereby decreasing sensitivity in some assay formats. Thus, a need exists for an approach to isolate nucleic acids from a cell sample that avoids the additional steps associated with lysis reagents and allows for release and detection from a single reagent addition step.